Recalls / Class II
Class IID-1069-2015
Product
Papaverine/phentolamine/prostaglandin 30/4/0.04 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
- Affected lot / code info
- Lot #: a) 1031-2014@51; Exp 3/18/15; b) 12152014@24; Exp 4/12/15
Why it was recalled
Lack of assurance of sterility
Recalling firm
- Firm
- Fallon Wellness Pharmacy, L.L.C.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 1057 Troy Schenectady Rd, N/A, Latham, New York 12110-1002
Distribution
- Quantity
- 15 vials
- Distribution pattern
- New York
Timeline
- Recall initiated
- 2015-03-17
- FDA classified
- 2015-05-12
- Posted by FDA
- 2015-05-20
- Terminated
- 2018-06-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1069-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.